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Bertsham, South Africa Clinical Trials

A listing of Bertsham, South Africa clinical trials actively recruiting patients volunteers.

RESULTS

Found (10) clinical trials

B/F/TAF FDC in HIV-1 Infected Virologically Suppressed Adolescents and Children

Cohort 1 and 2: The primary objectives of this study are: Part A: To evaluate the steady state pharmacokinetics (PK) of bictegravir (BIC) and confirm the dose of the bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) in HIV-1 infected, virologically suppressed adolescents (12 to < 18 years of ...

Phase

1.36 miles

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A Trial of Lopinavir/Ritonavir Dosed According to the Who Pediatric Weight Band Dosing Guidelines

This is a Phase II/III trial to assess the short-term pharmacokinetics, safety, and tolerance of LPV/r in HIV-infected infants and children initiating LPV/r therapy who weigh >3 and <25 kg and are dosed according to the WHO antiretroviral (ARV) weight band dosing guidelines. LPV/r will be administered as the heat-stable ...

Phase

1.36 miles

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Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)

This is a multi-centre, open label, multi-arm, randomised, controlled, phase II-III trial; evaluating short treatment regimens containing bedaquiline and pretomanid in combination with existing and re-purposed anti-TB drugs for the treatment of biologically confirmed pulmonary multidrug-resistant TB (MDR-TB). The study will be divided into two stages, with a seamless transition ...

Phase

3.6 miles

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Pharmacokinetics Safety and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

There will be 3 cohorts in this study. The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single tablet regimen (STR) (Part A) and to evaluate the safety and ...

Phase

3.6 miles

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Pharmacokinetics Safety and Efficacy of Cobicistat-boosted Atazanavir or Cobicistat-boosted Darunavir in HIV-1 Infected Treatment-Experienced Virologically Suppressed Pediatric Subjects

The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of cobicistat-boosted atazanavir (ATV/co) or cobicistat-boosted darunavir (DRV/co) in HIV-1 infected antiretroviral treatment-experienced, virologically suppressed, pediatric participants between the ages of 3 months to < 18 years of age. This study will also ...

Phase

4.65 miles

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Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a 2-NRTI-Containing Regimen

Cohorts 2, 3, and 4 will be on a boosted protease inhibitor (PI) or any other 3rd ARV agent and will switch their current 2-NRTI-containing regimen to open-label F/TAF while continuing their boosted PI or 3rd agent through 48 weeks. A minimum of 10 participants each in Groups 1 and ...

Phase

4.65 miles

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Trial to Evaluate the Efficacy Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients

Phase 2c multi-center, open-label, partially randomized clinical trial in DS-TB and DR-TB participants. All participants in the below arms will have follow-up for a period of 104 weeks (24 months) from the start of therapy. Participants with Drug Sensitive TB (DS-TB): Participants with DS-TB will be randomized to one of ...

Phase

4.65 miles

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A Multicenter Randomized Double-Blind Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to ...

Phase

6.4 miles

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A Randomised Trial of Dolutegravir (DTG)-Based Antiretroviral Therapy vs. Standard of Care (SOC) in Children With HIV Infection Starting First-line or Switching to Second-line ART

A new anti-HIV medicine (Dolutegravir) combined with 2 currently used anti-HIV medicines is non-inferior to the standard combination of medicines used in terms of efficacy and better in terms of toxicity.

Phase

8.87 miles

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Study to Evaluate Safety Tolerability Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure

This study consist of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study. The purpose for Part 2 ...

Phase

8.87 miles

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